Microbiome and Metabolomics Analysis in a Population of Infertile Patients Suffering From Non-obstructive Azospermia and Examination of Their Impact on the Reproductive Potential and Global Health of the Individual
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Prognostic role of the blood and semen samples
Study Overview
Brief Summary
The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.
Detailed Description
The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.
Furthermore, the study aims to assess if the blood and seminal alterations of infertile patients have similarities with the same fluids of elderly patients, validating from a metabolomic and microbiomic point of view the hypothesis of premature aging of infertile patients.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of idiopathic non-obstructive azoospermia
- •fertile men (pregnancy within 12 months from the start of the couple's search)
- •men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)
Exclusion Criteria
- •diagnosis of varicocele
- •endocrine alterations
- •chromosomal alterations
- •known genetic alterations
Outcomes
Primary Outcomes
Prognostic role of the blood and semen samples
Time Frame: Baseline
Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Salonia
Professor
IRCCS San Raffaele